You can access the general Swissmedic FAQs – which also apply to CHM, where relevant – at this link:
You can find answers to CHM-specific questions here:
1. Regulatory questions
1.1 For the authorisation of herbal medicinal products with traditional use (Art. 14 para. 1 let. cbis TPA), 30 years of medical use must be proven. What happens if the use/authorisation of a referenced comparator medicinal product is interrupted within the 30-year period?
1.2 The KPTPO applies to both human and veterinary medicinal products. Is it possible to authorise a medicinal product as both a human and veterinary medicinal product under the same authorisation number?
1.3 Are the Bach flower remedies also medicinal products authorised by Swissmedic?
1.4 How are food supplements distinguished from medicinal products?
The required 30 years of medicinal use must be a single continuous period as a general rule. Should an interruption in use have occurred, reasons must be given (must not have been due to safety concerns). This requirement also applies for 15 years of use in the EU/EFTA.
No, separate applications are required for human and veterinary medicinal products. This also applies to complementary medicines without indications. Separate authorisation numbers are issued.
Since 2006, the Bach flower remedies have been classed as foodstuffs and are subject to monitoring by the Federal Food Safety and Veterinary Office (FSVO). You can find information on the Bach flower remedies on the FSVO website.
Food supplements are foodstuffs; they are subject to food legislation and therefore to monitoring by the Federal Food Safety and Veterinary Office (FSVO).
You can find information on food supplements on the FSVO website.
Medicinal products are subject to therapeutic products legislation and are the responsibility of Swissmedic.
For delimitation questions, see:
2. Questions on quality
2.1 Does notification have to be given of a change in the geographic origin of herbal substances?
Is there a possibility of administrative simplification for multiple quality variation applications?
No application need be submitted to Swissmedic for a change in the geographic origin of herbal starting materials, provided that the specification for the herbal starting materials has not changed (-> specification variation).
Yes, multiple variations (type IA, type IB and/or type II) relating to the same quality variation template may be submitted as a single type II variation (z-variation of the respective variation template). The precondition is that all changed parameters be set out in detail in the “Present” / “Proposed” list (see guidance document Formal requirements HMV4, section 3.12.8).
You can ask your own questions and find links to more detailed information under
Last modification 20.03.2023